Adjustable Curved Guide Wire Assembly

Abstract

The present invention provides an adjustable bending guide wire assembly, which relates to the field of medical devices. The guide wire body includes a core tube, an outer bending adjustment tube, and an inner bending adjustment tube; the core tube includes a proximal section of the core tube and a distal section of the core tube pre-bent into a curled shape; the outer bending adjustment tube is sleeved outside the core tube, and at least its distal tube section is a helical tube, and the distal part of the helical tube follows the distal section of the core tube and bends into a pre-bent section in a curled shape; the inner bending adjustment tube axially slides between the core tube and the outer bending adjustment tube and has a hardness greater than that of the helical tube. By axially sliding the inner bending adjustment tube, the distal tube section of the inner bending adjustment tube can extend distally or retract proximally into the pre-bent section of the helical tube, thereby changing the curvature of the pre-bent section of the helical tube, and further changing the curvature of the distal section of the core tube. The adjustable bending guide wire assembly provided by the present invention has a simple structure, is easy to manufacture and operate, and the adjustable range of the angle of the distal end of the guide wire is not limited within 360°, and the adjustable range is wider, which is more conducive to adapting to complex intraluminal environments.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an adjustable bending guide wire assembly. Background Art

[0002] A guide wire, also known as a guiding wire or a guide lead, is one of the main tools for percutaneous catheterization. The guide wire has a guiding and supporting effect on the catheter, and is used to guide medical devices such as catheters and delivery sheaths into blood vessels and other body cavities, and smoothly reach the designated position or the lesion site. However, due to the natural curvature of blood vessels and the complex human anatomical structure, the guide wire may bend and coil in the lumen, thus affecting its passability.

[0003] During use, doctors have gradually felt that there are some problems with traditional guide wires, mainly including: traditional guide wires are non-adjustable in bending and have a single distal bending shape design. Each guide wire adopts a fixed bending shape design, which means that they are only suitable for specific types of blood vessels or cavity structures. When encountering different tortuous situations, the fixed-bending guide wire may encounter jamming problems and cannot smoothly pass through complex anatomical paths. Due to the anatomical structure differences among different patients and the different degrees and types of tortuosity that may occur during the same surgical procedure, the single-bending guide wire cannot meet all clinical needs.

[0004] In response to this, engineers in the medical field have developed some adjustable bending guide wires to alleviate the above technical problems. Taking the existing patent authorization announcement number CN204972649U as an example, the structure of these adjustable bending guide wires is introduced as follows: The existing patent authorization announcement number CN204972649U discloses an internal medicine intervention adjustable bending fishing guide wire. Its bending adjustment control end consists of a handle base, a handle screw rod, an adjustment wire, and a metal adjustment ring. Through the threaded cooperation between the handle screw rod and the handle base, the adjustment wire is pulled to move proximally, driving the metal adjustment ring to achieve the bending of the distal spring clip section. Although these guide wires represented by the existing patent authorization announcement number CN204972649U can achieve a certain bending adjustment function, there are still some problems, mainly including:

[0005] (1) The product structure is relatively complex, with many components, high requirements for production processes, and high operation complexity;

[0006] (2) The adjustment wire is parallel to the guide wire. During the bending adjustment process, not only the distal end of the guide wire bends, but the proximal end will also bend to a certain extent due to the force. This bending state will cause the torsional controllability of the guide wire to deteriorate, which is not conducive to the guide wire pointing to the designated position in the lumen;

[0007] (3) The bending angle is limited. Although the existing adjustable bending guide wires can adjust the front-end bending angle to a certain extent, the achievable angle change range is still relatively limited and is not sufficient to cope with some complex lumen environments;

[0008] (4) The guide wire body is fixedly connected to the operating handle. After the guide wire reaches the designated position, the bending adjustment handle cannot be disassembled, which is not conducive to the catheter passing through the guide wire for exchange;

[0009] (5) In the prior art, the softness and hardness of the guide wire are single and non-adjustable. The guide wire is mostly of a single hardness or a gradually changing hardness in segments. As the guide wire passes through tortuous environments, the hardness requirements for its proximal and distal positions may not be fixed. Therefore, the adaptability of the softness and hardness of the existing guide wire to the tortuous vascular environment is not high, and it is easy to damage the blood vessels or fail to reach the target position. SUMMARY OF THE INVENTION

[0010] The purpose of the present invention is to provide an adjustable bending guide wire assembly to alleviate the technical problems existing in the prior art.

[0011] To achieve the above object, the embodiments of the present invention adopt the following technical solutions:

[0012] The embodiments of the present invention provide an adjustable bending guide wire assembly, including a guide wire body, and the guide wire body includes a core tube, a bending adjustment inner tube, and a bending adjustment outer tube; wherein:

[0013] The core tube includes a proximal section of the core tube and a distal section of the core tube pre-bent into a curly shape;

[0014] The bending adjustment outer tube is sleeved outside the core tube, and at least its distal tube section is a coiled tube. The distal part of the coiled tube is sleeved outside the distal section of the core tube to form a pre-bent section that follows the distal section of the core tube and bends into a curly shape;

[0015] The bending adjustment inner tube is axially slidably arranged between the outer wall of the core tube and the inner wall of the bending adjustment outer tube, and the hardness of the bending adjustment inner tube is greater than the hardness of the coiled tube;

[0016] Axially sliding the bending adjustment inner tube relative to the core tube and the bending adjustment outer tube, the distal tube section of the bending adjustment inner tube can extend distally or retract proximally into the pre-bent section of the coiled tube, thereby changing the bending degree of the pre-bent section of the coiled tube, and further changing the bending degree of the distal section of the core tube.

[0017] The embodiments of the present invention can at least achieve the following beneficial effects:

[0018] In the adjustable bending guide wire assembly provided in this embodiment, the distal pipe section of the inner bending pipe is a straight pipe section. When it extends distally into the pre-bent section of the spring-wound pipe, it will straighten the proximal area of the pre-bent section. Since the pre-bent section is also part of the spring-wound pipe, the spring pitch of the pre-bent section is reduced, and the pre-bent section pulls the distal pipe section of the coiled core pipe inside it, causing a corresponding change in the bending degree (coiling degree) of the distal pipe section of the core pipe. When the straight distal pipe section of the inner bending pipe is withdrawn from the spring-wound pipe proximally, the pre-bent section and the distal pipe section of the core pipe self-elasticly return to the prefabricated bending degree, thereby adjusting the distal curvature of the guide wire body according to the actual vascular tortuosity of the patient.

[0019] The structure of this embodiment is simple and easy to manufacture. In terms of the adjustment method, it is adjusted by axially sliding the inner bending pipe relative to the other two layers of pipes on the basis of the three-layer pipes of the core pipe, the inner bending pipe, and the outer bending pipe, which is convenient for operation and will not affect the torsional controllability of the guide wire body during the adjustment process. Therefore, the directivity is stronger, and it is more conducive to the guide wire body pointing to the specified position in the cavity. In addition, since the pre-bent section of the spring-wound pipe and the distal pipe section of the core pipe inside it can be prefabricated into a coiled shape, and the number of coiled layers is not limited. For example, it can be half a turn, one turn, two turns, etc. Then, by controlling the degree of straightening, the number of layers can be adjusted. Therefore, it can adapt to the vascular tortuous turning angle at any angle (including greater than or equal to 360°) in space, and the adjustable range of the head angle of the guide wire body is wider, which is more conducive to adapting to the complex cavity environment.

[0020] In addition, the embodiment of the present invention also has a variety of optional implementation manners, including:

[0021] In an optional implementation manner, in the core pipe, at least the distal pipe section of the core pipe is a solid pipe section, and the distal end of the proximal pipe section of the core pipe and the proximal end of the distal pipe section of the core pipe are transitionally connected through a gradually tapered transition section with a diameter gradually decreasing from the proximal end to the distal end.

[0022] In an optional implementation manner, the outer bending pipe further includes a straight proximal connecting pipe; an initial positioning structure for initially positioning the outer bending pipe on the inner bending pipe is further provided between the inner wall of the proximal connecting pipe and the outer wall of the inner bending pipe; the initial positioning structure includes an arc-shaped positioning groove provided on one of the inner wall of the proximal connecting pipe and the outer wall of the inner bending pipe and an arc-shaped positioning protrusion provided on the other.

[0023] In an optional implementation manner, the adjustable bending guide wire assembly further includes an adjustment core wire for adjusting the hardness of the guide wire body; at least the proximal pipe section of the core pipe is a hollow pipe section, the distal end of the adjustment core wire is inserted into the core pipe from the proximal pipe orifice of the proximal pipe section of the core pipe, the proximal end of the adjustment core wire is exposed outside the core pipe, and the adjustment core wire can axially slide relative to the core pipe.

[0024] In an alternative embodiment, the deflectable outer tube further includes a straight proximal connecting tube; the proximal connecting tube, the proximal section of the core tube, and the deflectable inner tube are all rigid tubes;

[0025] The deflectable guide wire assembly further includes a handle tube, a first fixing sleeve, and a second fixing sleeve;

[0026] The first fixing sleeve is nested inside the handle tube, and the proximal section of the core tube is nested and connected to the inside of the first fixing sleeve with an interference fit;

[0027] The second fixing sleeve is disposed between the outer wall of the proximal section of the core tube and the inner wall of the proximal tube section of the deflectable inner tube and is in frictional engagement with the outer wall of the proximal section of the core tube and the inner wall of the proximal tube section of the deflectable inner tube respectively.

[0028] In an alternative embodiment, the distal tube section of the first fixing sleeve has a smaller diameter than the proximal tube section, so as to form a stepped hole between the outer peripheral surface of the distal tube section of the first fixing sleeve and the inner peripheral surface of the distal tube section of the handle tube; the proximal tube section of the deflectable inner tube is inserted into the stepped hole and is in frictional engagement with the hole wall of the stepped hole.

[0029] In an alternative embodiment, the deflectable guide wire assembly further includes a detachable operating handle, and the detachable operating handle includes a handle housing, a handle tube fixing assembly, a deflectable outer tube fixing assembly, a deflectable inner tube driving assembly, and a deflectable inner tube locking member;

[0030] The handle housing is internally provided with a handle housing cavity extending axially and at least penetrating the distal end face of the handle housing, and at least the part of the guide wire body located on the proximal side of the proximal connecting tube and the entire proximal connecting tube are inserted into the handle housing cavity;

[0031] At least part of the handle tube fixing assembly is disposed in the handle housing cavity and is in frictional engagement with the outer wall of the handle tube, so as to fix the handle tube in the handle housing cavity; at least part of the deflectable outer tube fixing assembly is disposed in the handle housing cavity and is in frictional engagement with the outer wall of the proximal connecting tube, so as to fix the proximal connecting tube in the handle housing cavity;

[0032] On the handle housing, there is a driving long hole penetrating the housing wall of the handle housing radially and extending axially along the handle housing; a part of the deflectable inner tube driving assembly passes through the driving long hole and extends into the handle housing cavity to be in frictional engagement with the outer wall of the proximal tube section of the deflectable inner tube, and the other part of the deflectable inner tube driving assembly is located outside the handle housing; the deflectable inner tube driving assembly can axially slide relative to the handle housing along the driving long hole to drive the deflectable inner tube to axially slide along the handle housing;

[0033] The inner tube bending adjustment locking piece is movably mounted on the outside of the handle shell, and is used to lock the inner tube bending adjustment driving assembly to the handle shell when the inner tube bending adjustment driving assembly axially slides into place.

[0034] Further, in an optional embodiment, the handle tube fixing assembly, the bending outer tube fixing assembly and the bending inner tube driving assembly respectively include at least one group of extrusion assemblies, each group of the extrusion assemblies respectively includes two extrusion structures symmetrically arranged on both sides of the handle shell along the radial direction of the handle shell, each of the extrusion structures respectively includes a columnar connecting member and a soft friction pad connected to one end of the columnar connecting member, the soft friction pad is arranged inside the inner cavity of the handle shell, and the columnar connecting member passes through the shell wall of the handle shell along the radial direction of the handle shell, wherein:

[0035] The soft friction pad of the handle tube fixing assembly is frictionally matched with the outer tube wall of the handle tube; one end of the columnar connecting member of the handle tube fixing assembly away from the inner cavity of the handle shell is fixed to the handle shell through a fixing member;

[0036] The soft friction pad of the bending outer tube fixing assembly is frictionally matched with the outer tube wall of the proximal connecting tube; one end of the columnar connecting member of the bending outer tube fixing assembly away from the inner cavity of the handle shell is fixed to the handle shell through another fixing member;

[0037] The soft friction pad of the bending inner tube driving assembly is frictionally matched with the outer wall of the proximal tube section of the bending inner tube; the columnar connecting piece of the bending inner tube driving assembly passes through the driving long hole and its end away from the inner cavity of the handle shell is exposed to the outside of the handle shell, and the bending inner tube locking piece is transmission connected to the columnar connecting piece of the bending inner tube driving assembly, and is used to lock the columnar connecting piece of the bending inner tube driving assembly to the handle shell when the bending inner tube driving assembly slides axially into place.

[0038] Further, in an optional embodiment, the handle shell includes a first shell member, a second shell member, a third shell member and a fourth shell member;

[0039] The second shell member includes a cylindrical body and an end plate connected to the distal end of the cylindrical body and extending radially outward along the cylindrical body. The handle shell inner cavity is provided inside the cylindrical body, and the handle shell inner cavity extends along the axial direction of the cylindrical body and passes through the end plate; the proximal end of the cylindrical body is docked with the distal end of the first shell member through a shell docking member, and the proximal end surface of the end plate and the distal end surface of the first shell member face each other; two rows of first ratchet teeth are respectively arranged on the proximal end surface of the end plate and the distal end surface of the first shell member along the radial direction of the cylindrical body on both sides of the cylindrical body;

[0040] The third shell member and the fourth shell member are respectively arranged on both sides of the cylindrical body along the radial direction of the cylindrical body, and second ratchet teeth are respectively provided on the two end surfaces of the third shell member and the fourth shell member along the axial direction of the cylindrical body; the second ratchet teeth on the proximal end surfaces of the third shell member and the fourth shell member are respectively meshed with the first ratchet teeth on the distal end surface of the first shell member, and the second ratchet teeth on the distal end surfaces of the third shell member and the fourth shell member are respectively meshed with the first ratchet teeth on the proximal end surface of the end plate, and the meshing direction of the first ratchet teeth and the second ratchet teeth allows the third shell member and the fourth shell member to approach each other in the radial direction of the cylindrical body and prevents the third shell member and the fourth shell member from moving away from each other in the radial direction of the cylindrical body;

[0041] In the handle tube fixing assembly and the bending outer tube fixing assembly, respectively: at least one columnar connecting member of the extruded structure passes through the third shell member and the tubular body, and is fixedly connected to the third shell member via a fixing member; at least one columnar connecting member of the extruded structure passes through the fourth shell member and the tubular body, and is fixedly connected to the fourth shell member via a fixing member;

[0042] In the inner tube bending drive assembly, at least one of the columnar connecting members of the extruded structure passes through an axial long hole that is radially penetrating and extending in the axial direction and is provided on the third shell member, and at least one of the columnar connecting members of the extruded structure passes through an axial long hole that is radially penetrating and extending in the axial direction and is provided on the fourth shell member;

[0043] The inner tube bending adjustment locking member is movably mounted outside the third housing member and the fourth housing member and is drivingly connected to the columnar connecting member of the inner tube bending adjustment driving assembly.

[0044] Further, in an optional embodiment, the inner tube bending locking member includes a knob sleeve, and a knob thread is provided on the outer circumference of the third shell member and the fourth shell member around the circumference of the cylindrical body and extending along the axial direction of the cylindrical body; the knob sleeve is sleeved on the outside of the third shell member and the fourth shell member and is threadedly connected with the knob thread;

[0045] An end buckle is respectively provided at one end of the columnar connecting piece of the bending inner tube driving assembly away from the cylindrical body, and an annular groove extending circumferentially along the cylindrical body is provided on the proximal surface of the knob sleeve, and the end buckle is buckled in the annular groove; the knob sleeve rotates circumferentially around the cylindrical body and can slide axially along the cylindrical body with the bending inner tube driving assembly.

[0046] In an alternative embodiment, the housing docking member includes a columnar insertion portion and a blocking portion connected to one end of the columnar insertion portion. An axial insertion hole axially penetrating the columnar insertion portion and the blocking portion is provided inside the columnar insertion portion; an external thread is provided on the outer surface of the distal end of the columnar insertion portion.

[0047] A connection hole penetrating the proximal surface of the second housing member is provided at the proximal end of the second housing member. The connection hole communicates with the inner cavity of the handle housing, and an internal thread is provided on the hole wall of the connection hole; the columnar insertion portion passes through the first housing member and then is inserted into the connection hole and is threadedly connected to the connection hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0049] Figure 1 It is a schematic diagram of the overall structure of an alternative embodiment of the guide wire body (without an adjustment core wire) in the adjustable bending guide wire assembly provided by the present invention;

[0050] Figure 2 For Figure 1 A broken view of the structure shown;

[0051] Figure 3 For Figure 1 A partial enlarged view of area A in;

[0052] Figure 4 For Figure 1 A partial enlarged view of area B in;

[0053] Figure 5 For Figure 1 A partial enlarged view of area C in;

[0054] Figure 6 It is a schematic diagram of the overall structure of the adjustment core wire in another alternative embodiment of the guide wire body in the adjustable bending guide wire assembly provided by the present invention;

[0055] Figure 7 For Figure 6 A broken view of the adjustment core wire shown;

[0056] Figure 8 It is a schematic diagram of the overall structure of an alternative embodiment of the detachable operation handle in the adjustable bending guide wire assembly provided by the present invention;

[0057] Figure 9 Schematic diagram of the structure of a driving long hole provided on the cylindrical main body of the second housing member in Figure 8 Figure 8 ;

[0058] Figure 10 In the adjustable bending guide wire assembly provided by the present invention, Figure 6 Schematic diagram of the assembly structure of the shown guide wire main body and Figure 8 the detachable operating handle shown;

[0059] Figure 11 is Figure 10 a broken view of the shown assembly structure;

[0060] Figure 12 is Figure 10 an enlarged view of the local structure of area D in

[0061] Figure 13 is Figure 10 an enlarged view of the local structure of area E in

[0062] Figure 14 is Figure 10 an enlarged view of the local structure of area F in

[0063] Icon: 100 - guide wire main body; 1 - core tube; 11 - proximal section of the core tube; 12 - distal section of the core tube; 13 - tapered transition section; 2 - bending adjustment outer tube; 21 - spring winding tube; 22 - proximal connecting tube; 220 - initial positioning structure; 2201 - arc-shaped positioning groove; 2202 - arc-shaped positioning protrusion; 211 - pre-bent section; 3 - bending adjustment inner tube; 4 - adjustment core wire; 41 - core wire handle; 51 - handle tube; 52 - first fixing sleeve; 521 - stepped hole; 53 - second fixing sleeve; 200 - detachable operating handle; 6 - handle housing; 601 - first ratchet tooth; 602 - second ratchet tooth; 603 - knob thread; 61 - first housing member; 62 - second housing member; 621 - cylindrical main body; 622 - end plate; 63 - third housing member; 64 - fourth housing member; 6001 - inner cavity of the handle housing; 6002 - driving long hole; 65 - housing docking member; 650 - axial insertion hole; 651 - cylindrical insertion portion; 652 - blocking portion; 7 - handle tube fixing assembly; 8 - bending adjustment outer tube fixing assembly; 9 - bending adjustment inner tube driving assembly; 10 - bending adjustment inner tube locking member; 101 - knob sleeve; 1011 - annular clamping groove; 201 - cylindrical connecting member; 2011 - end buckle; 202 - soft friction pad; 203 - fixing member. Detailed implementation manners

[0064] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. Components of the embodiments of the present invention usually described and illustrated in the accompanying drawings here can be arranged and designed in various different configurations.

[0065] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0066] It should be noted that like reference numerals and letters denote like items in the accompanying drawings. Therefore, once an item is defined in one of the accompanying drawings, it does not need to be further defined and explained in subsequent drawings.

[0067] In the description of the present invention, it should be noted that:

[0068] Unless otherwise clearly defined and limited, the terms "arrangement", "installation", and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0069] The orientation or positional relationship indicated by terms such as "proximal end", "distal end", "front end", "rear end", "axial direction", "radial direction", "inner", and "outer" is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the present invention is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

[0070] The terms "first", "second", etc. are only used for distinguishing descriptions, and do not represent a total number, or a relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0071] Hereinafter, taking the end of a medical device closer to the operator during surgery as the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel as the distal end of the medical device (the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end); with reference to the accompanying drawings, some embodiments of the present invention will be described in detail.

[0072] This embodiment provides an adjustable bending guide wire assembly. Refer to Figures 1 to 5 The adjustable bending guide wire assembly provided in this embodiment includes a guide wire main body 100, and the guide wire main body 100 includes a core tube 1, a bending adjustment outer tube 2, and a bending adjustment inner tube 3, where: The core tube 1 includes a core tube proximal section 11 and a core tube distal section 12 pre-bent into a curly shape. The bending adjustment outer tube 2 is sleeved outside the core tube 1, and at least its distal tube section is a coiled tube 21. The distal part of the coiled tube 21 is sleeved outside the core tube distal section 12 to form a pre-bent section 211 that bends into a curly shape following the core tube distal section 12. The bending adjustment inner tube 3 is axially slidably arranged between the outer wall of the core tube 1 and the inner wall of the bending adjustment outer tube 2, and at least the distal tube section of the bending adjustment inner tube 3 is a straight tube section with a hardness greater than that of the coiled tube 21. When the bending adjustment inner tube 3 slides axially relative to the core tube 1 and the bending adjustment outer tube 2, the distal tube section of the bending adjustment inner tube 3 can extend distally or retract proximally into the pre-bent section 211 of the coiled tube 21, thereby changing the bending degree (curling degree) of the pre-bent section 211 of the coiled tube 21, and further changing the bending degree (curling degree) of the core tube distal section 12.

[0073] It should be specifically noted that the above coiled tube 21 can be a spiral wound wire tube structure, can also be obtained by helically slitting a metal pipe fitting, or can be made by other processes. This application does not make specific limitations on this.

[0074] In the above adjustable bending guide wire assembly provided in this embodiment, as Figure 5 shown, the distal tube section of the bending adjustment inner tube 3 is a straight tube section. When it extends distally into the pre-bent section 211 of the coiled tube 21, it will straighten the proximal region of the pre-bent section 211. And since the pre-bent section 211 is also a part of the coiled tube 21, the spring pitch of the pre-bent section 211 is reduced. The pre-bent section 211 pulls the coiled core tube distal section 12 inside it, causing the bending degree (curling degree) of the core tube distal section 12 to change accordingly. When the straight distal tube section of the bending adjustment inner tube 3 retracts proximally from the coiled tube 21, the pre-bent section 211 and the core tube distal section 12 self-elasticly return to the prefabricated bending degree, thereby adjusting the distal curvature of the guide wire main body 100 according to the actual vascular tortuosity state of the patient.

[0075] This embodiment has a simple structure and is easy to manufacture. In terms of the adjustment method, on the basis of the three-layer tubes of the core tube 1, the inner bending adjustment tube 3, and the outer bending adjustment tube 2, the inner bending adjustment tube 3 is axially slid relative to the other two layers of tubes for adjustment, which is convenient for operation and will not affect the torsional control of the guide wire body 100 during the adjustment process, so the directivity is stronger and it is more conducive to the guide wire body 100 pointing to the specified position in the cavity. In addition, since the pre-bent section 211 of the coil tube 21 and the distal section 12 of the core tube inside it can be prefabricated into a curled shape, and the number of curled layers is not limited. For example, it can be half a turn, one turn, two turns, etc. Then, by controlling the degree of straightening, the number of layers can be adjusted. Therefore, it can adapt to the vascular tortuous turns at any angle (including greater than or equal to 360°) in the space, and the adjustable range of the head end angle of the guide wire body 100 is wider, which is more conducive to adapting to the complex intracavitary environment.

[0076] In this embodiment, for the more specific structure of the above-mentioned guide wire body 100, optionally, the structure of the core tube 1 can be an integral solid tubular structure or an integral hollow tubular structure, or a combination of a hollow tubular structure and a solid tubular structure. Optionally, at least the distal section 12 of the core tube is a solid tube section, and the distal end of the proximal section 11 of the core tube is transitionally connected to the proximal end of the distal section 12 of the core tube through a gradually tapered transition section 13 with a diameter gradually decreasing from the proximal end to the distal end. That is, the diameter of the proximal section 11 of the core tube is greater than the diameter of the distal section 12 of the core tube. The distal section 12 of the core tube being a solid tube section can be regarded as the distal section 12 of the core tube being a filamentous structure. Thus, it can ensure that the proximal section 11 of the core tube has a certain supporting force to maintain the torsional control of the proximal end of the core tube 1 and ensure that the guide wire head reaches the target position more accurately, and can also ensure that the distal section 12 of the core tube has good bending plasticity to adapt to various tortuous angles of blood vessels.

[0077] Optionally, in addition to the coil tube 21 at the distal end, the outer bending adjustment tube 2 further includes a straight proximal connecting tube 22; the distal end of the proximal connecting tube 22 is fixedly connected to the proximal end of the coil tube 21, such as Figure 4As shown, an initial positioning structure 220 is further provided between the inner wall of the proximal connecting tube 22 and the outer wall of the bending inner tube 3 for initially positioning the bending outer tube 2 relative to the bending inner tube 3; the initial positioning structure 220 includes an arc-shaped positioning groove 2201 provided on one of the inner wall of the proximal connecting tube 22 and the outer wall of the bending inner tube 3 and an arc-shaped positioning protrusion 2202 provided on the other. By providing the initial positioning structure 220, the proximal connecting tube 22 of the bending outer tube 2 and the bending inner tube 3 can be initially positioned during use, preventing the phenomenon of "random movement" of the head end angle of the guide wire body 100 during the process of inserting the guide wire body 100 into the patient's cavity, which is more conducive to the delivery of the guide wire body 100. Since the initial positioning structure 220 is a combined structure of an arc-shaped positioning groove 2201 and an arc-shaped positioning protrusion 2202, thus, after being delivered in place, when the bending inner tube 3 slides axially relative to the bending outer tube 2, it can smoothly slide through the arc-shaped area of the initial positioning structure 220 with a little force to achieve the bending function.

[0078] In addition, in an alternative embodiment of the present embodiment, referring to Figure 6 and Figure 7 , in combination with Figure 10 , Figure 11 and Figure 14 , the adjustable bending guide wire assembly provided in the present embodiment may further include an adjusting core wire 4 for adjusting the hardness of the guide wire body 100; at least the proximal section 11 of the core tube 1 is a hollow tube section, the distal end of the adjusting core wire 4 is inserted into the core tube 1 from the proximal pipe orifice of the proximal section 11 of the core tube, the proximal end of the adjusting core wire 4 is exposed outside the core tube 1, and the adjusting core wire 4 can axially slide relative to the core tube 1. This design is an improvement in response to the problems of the existing guide wire having a single non-adjustable softness and hardness, low adaptability to tortuous vascular environments, being prone to damaging blood vessels or being unable to reach the target position. By pushing the adjusting core wire 4 forward (distally) or pulling it backward (proximally), the hardness of the proximal section 11 of the core tube is changed, realizing the function of adjusting the hardness of the proximal section 11 of the core tube in real time and thus adjusting the hardness of the guide wire body 100 in real time, so that the softness and hardness of the guide wire body 100 can be arbitrarily controlled, thereby adapting to the vascular environment of the region and smoothly reaching the lesion site without damaging the blood vessels.

[0079] To further improve the delivery and bending stability of the guide wire body 100, continue to refer to Figures 1 to 5, in an alternative embodiment of the steerable guide wire assembly provided in this embodiment, the outer bending tube 2 further includes a straight proximal connecting tube 22; the proximal connecting tube 22, the proximal section of the core tube 11, and the inner bending tube 3 are all rigid tubes; the steerable guide wire assembly further includes a handle tube 51, a first fixing sleeve 52, and a second fixing sleeve 53. The first fixing sleeve 52 is nested inside the handle tube 51, and the proximal section of the core tube 11 is nested and interference-fitted inside the first fixing sleeve 52. The second fixing sleeve 53 is disposed between the outer wall of the proximal section of the core tube 11 and the inner wall of the proximal tube section of the inner bending tube 3 and is in frictional engagement with the outer wall of the proximal section of the core tube 11 and the inner wall of the proximal tube section of the inner bending tube 3 respectively. In this structure, the proximal section of the core tube 11 is fixed by the handle tube 51 and the first fixing sleeve 52, and the second fixing sleeve 53 maintains the gap between the inner bending tube 3 and the proximal section of the core tube 11, preventing the inner bending tube 3 from wobbling relative to the proximal section of the core tube 11 when delivering the guide wire body 100 and axially sliding the inner bending tube 3 for bending, thereby improving the stability when delivering the guide wire body 100 and bending the head end of the guide wire body 100.

[0080] Further, the diameter of the distal tube section of the first fixing sleeve 52 can be further designed to be smaller than the diameter of the proximal tube section, so as to form a stepped hole 521 between the outer peripheral surface of the distal tube section of the first fixing sleeve 52 and the inner peripheral surface of the distal tube section of the handle tube 51; the proximal tube section of the inner bending tube 3 is inserted into the stepped hole 521 and is in frictional engagement with the hole wall of the stepped hole 521, serving as the initial adjustment position of the inner bending tube 3, further preventing the inner bending tube 3 from wobbling during delivery and increasing the delivery stability of the guide wire body 100.

[0081] To further facilitate the operation of the surgeon, referring to Figures 8 to 14 , in combination with Figures 1 to 5, in some alternative embodiments of the present embodiment, the bendable guide wire assembly further includes a detachable operating handle 200, and the detachable operating handle 200 includes a handle housing 6, a handle tube fixing assembly 7, a bending outer tube fixing assembly 8, a bending inner tube driving assembly 9, and a bending inner tube locking member 10. Inside the handle housing 6, there is a handle housing inner cavity 6001 extending axially and at least penetrating the distal end surface of the handle housing 6. At least the part of the guide wire body 100 located on the proximal side of the proximal connecting tube 22 and the entire proximal connecting tube 22 are inserted into the handle housing inner cavity 6001. At least a part of the handle tube fixing assembly 7 is arranged in the handle housing inner cavity 6001 and frictionally cooperates with the outer tube wall of the handle tube 51, so as to fix the handle tube 51 in the handle housing inner cavity 6001. At least a part of the bending outer tube fixing assembly 8 is arranged in the handle housing inner cavity 6001 and frictionally cooperates with the outer tube wall of the proximal connecting tube 22, so as to fix the proximal connecting tube 22 in the handle housing inner cavity 6001. On the handle housing 6, there is a driving long hole 6002 penetrating the housing wall of the handle housing 6 radially and extending axially along the handle housing 6; a part of the bending inner tube driving assembly 9 passes through the driving long hole 6002 and extends into the handle housing inner cavity 6001 to frictionally cooperate with the outer tube wall of the proximal tube section of the bending inner tube 3, and the other part of the bending inner tube driving assembly 9 is located outside the handle housing 6; the bending inner tube driving assembly 9 can axially slide relative to the handle housing 6 along the driving long hole 6002 to drive the bending inner tube 3 to axially slide along the handle housing 6. The bending inner tube locking member 10 is movably installed outside the handle housing 6 and is used to lock the bending inner tube driving assembly 9 to the handle housing 6 when the bending inner tube driving assembly 9 axially slides in place. This alternative embodiment provides a detachable operating handle 200, which is assembled with the guide wire body 100 provided in any of the foregoing alternative embodiments. The proximal section of the fixed core tube 11 can be detachably fixed through the frictional cooperation between the handle tube fixing assembly 7 and the handle tube 51, the proximal tube section of the bending outer tube 2 can be detachably fixed through the frictional cooperation between the bending outer tube fixing assembly 8 and the proximal connecting tube 22, and the bending inner tube 3 is driven to axially slide through the bending inner tube driving assembly 9. When the bending inner tube driving assembly 9 axially slides in place, the bending inner tube driving assembly 9 is locked by the bending inner tube locking member 10, and then the bending inner tube 3 is locked, completing the entire process of delivering the guide wire body 100 to the target position. After completion, the detachable operating handle 200 can be removed, and other subsequent instruments for treatment (such as a covered stent delivery sheath) can be inserted along the delivered guide wire body 100. The structural design of the detachable operating handle 200 is based on the principle of frictional fit positioning, and it can be detached from the guide wire body 100 after the guide wire body 100 is delivered in place, and the subsequent instrument is inserted using the guide wire body 100, which is beneficial for the exchange of the subsequent instrument sheath through the guide wire and solves the problem that the guide wire body 100 is too thin and difficult to deliver.

[0082] Continue to refer to Figures 8 to 13, Further optionally, the above-mentioned handle tube fixing assembly 7, the bending outer tube fixing assembly 8 and the bending inner tube driving assembly 9 respectively include at least one set of extrusion assemblies, and each set of extrusion assemblies respectively includes two extrusion structures symmetrically arranged on both sides of the handle shell 6 along the radial direction of the handle shell 6. Each extrusion structure respectively includes a columnar connecting piece 201 and a soft friction pad 202 connected to one end of the columnar connecting piece 201. The soft friction pad 202 is arranged inside the inner cavity 6001 of the handle shell, and the columnar connecting piece 201 passes through the shell wall of the handle shell 6 along the radial direction of the handle shell 6. Among them: the soft friction pad 202 of the handle tube fixing assembly 7 is in frictional cooperation with the outer tube wall of the handle tube 51; one end of the columnar connecting piece 201 of the handle tube fixing assembly 7 far from the inner cavity 6001 of the handle shell is fixed to the handle shell 6 through a fixing piece 203. The soft friction pad 202 of the bending outer tube fixing assembly 8 is in frictional cooperation with the outer tube wall of the proximal connecting tube 22; one end of the columnar connecting piece 201 of the bending outer tube fixing assembly 8 far from the inner cavity 6001 of the handle shell is fixed to the handle shell 6 through another fixing piece 203. The soft friction pad 202 of the bending inner tube driving assembly 9 is in frictional cooperation with the outer tube wall of the proximal tube section of the bending inner tube 3; the columnar connecting piece 201 of the bending inner tube driving assembly 9 passes through the driving long hole 6002 on the handle shell 6 and one end of it far from the inner cavity 6001 of the handle shell extends out of the handle shell 6. The bending inner tube locking piece 10 is in transmission connection with the columnar connecting piece 201 of the bending inner tube driving assembly 9 and is used to lock the columnar connecting piece 201 of the bending inner tube driving assembly 9 to the handle shell 6 when the bending inner tube driving assembly 9 slides axially in place. For the convenience of production and manufacturing, especially for the convenience of putting the soft friction pads 202 of the handle tube fixing assembly 7, the bending outer tube fixing assembly 8 and the bending inner tube driving assembly 9 into the inner cavity 6001 of the handle shell, optionally, the handle shell 6 is set as a multi-shell structure formed by at least two half-shells buckling to form the inner cavity 6001 of the handle shell.

[0083] Continue to refer to Figures 8 to 13 , with emphasis on referring to Figure 8 and Figures 11 to 13, further optionally, the handle shell 6 includes a first shell member 61, a second shell member 62, a third shell member 63 and a fourth shell member 64; wherein: the second shell member 62 includes a cylindrical body 621 and an end plate 622 connected to the distal end of the cylindrical body 621 and extending radially outward along the cylindrical body 621, and the handle shell inner cavity 6001 is provided inside the cylindrical body 621, and the handle shell inner cavity 6001 extends along the axial direction of the cylindrical body 621 and passes through the end plate 622; the proximal end of the cylindrical body 621 is docked with the distal end of the first shell member 61 through a shell docking member 65, and the proximal end surface of the end plate 622 in the second shell member 62 faces the distal end surface of the first shell member 61; two rows of first ratchet teeth 601 arranged radially on both sides of the cylindrical body 621 along the cylindrical body 621 are respectively provided on the proximal end surface of the end plate 622 in the second shell member 62 and the distal end surface of the first shell member 61. The third housing member 63 and the fourth housing member 64 are respectively arranged on both sides of the cylindrical body 621 along the radial direction of the cylindrical body 621, and second ratchet teeth 602 are respectively arranged on the surfaces of both ends of the third housing member 63 and the fourth housing member 64 along the axial direction of the cylindrical body 621. The second ratchet teeth 602 on the proximal surfaces of the third housing member 63 and the fourth housing member 64 are respectively meshed with the first ratchet teeth 601 on the distal surface of the first housing member 61, and the second ratchet teeth 602 on the distal surfaces of the third housing member 63 and the fourth housing member 64 are respectively meshed with the first ratchet teeth 601 on the proximal surface of the middle end plate 622 of the second housing member 62. The meshing direction of the first ratchet teeth 601 and the second ratchet teeth 602 allows the third housing member 63 and the fourth housing member 64 to approach each other along the radial direction of the cylindrical body 621, and prevents the third housing member 63 and the fourth housing member 64 from moving away from each other along the radial direction of the cylindrical body 621. In the handle tube fixing assembly 7 and the bending outer tube fixing assembly 8, respectively: at least one columnar connector 201 of an extruded structure passes through the third housing member 63 and the cylindrical body 621, and is fixedly connected to the third housing member 63 through a fixing member 203, and at least one columnar connector 201 of an extruded structure passes through the fourth housing member 64 and the cylindrical body 621, and is fixedly connected to the fourth housing member 64 through another fixing member 203. In the bending inner tube driving assembly 9, at least one columnar connector 201 of an extruded structure passes through an axial long hole that is radially penetrating and extending in the axial direction and is provided on the third housing member 63, and at least one columnar connector 201 of an extruded structure passes through an axial long hole that is radially penetrating and extending in the axial direction and is provided on the fourth housing member 64. The inner tube bending locking member 10 is movably mounted outside the third housing member 63 and the fourth housing member 64 and is in driving connection with the columnar connecting member 201 of the inner tube bending driving assembly 9, so as to lock the inner tube bending driving assembly 9 to the third housing member 63 or the fourth housing member 64 when the inner tube bending driving assembly 9 slides axially into place. The second housing member 62 is preferably formed by butting two half housings with arc-shaped grooves to form the handle shell cavity 6001, and the third housing member 63 and the fourth housing member 64 are preferably arc-shaped plates.Since the meshing directions of the first ratchet 601 and the second ratchet 602 allow the third housing member 63 and the fourth housing member 64 to approach each other radially along the tubular main body 621 and prevent the third housing member 63 and the fourth housing member 64 from moving away from each other radially along the tubular main body 621, thus, the third housing member 63 and the fourth housing member 64 can approach each other radially along the tubular main body 621 so that each soft friction pad 202 is tightly held on the corresponding pipe wall. When the detachable operating handle 200 needs to be removed, the axial positioning between the first housing member 61 and the second housing member 62 is released, and move axially away from the first housing member 61 and the second housing member 62, and then move the third housing member 63 and the fourth housing member 64 away from each other radially along the tubular main body 621, and the locking of the guide wire main body 100 can be released, and the detachable operating handle 200 can be slipped proximally off the guide wire main body 100.

[0084] For the bending inner tube locking member 10, a clamp or a buckle or other optional locking structural members can be selected. For the convenience of operation, refer to Figure 8 , optionally, the above-mentioned bending inner tube locking member 10 includes a knob sleeve 101. A knob thread 603 is provided on the outer peripheral surfaces of the third housing member 63 and the fourth housing member 64, which circumferentially surrounds the tubular main body 621 and axially extends along the tubular main body 621; the knob sleeve 101 is sleeved outside the third housing member 63 and the fourth housing member 64 and is threadedly connected to the knob thread 603. End buckles 2011 are respectively provided at one ends of the columnar connecting member 201 of the bending inner tube driving assembly 9 away from the tubular main body 621. An annular clamping groove 1011 extending circumferentially along the tubular main body 621 is provided on the proximal end surface of the knob sleeve 101, and the aforementioned end buckles 2011 are buckled inside the annular clamping groove 1011; when the knob sleeve 101 rotates circumferentially around the tubular main body 621, it can drive the bending inner tube driving assembly 9 to slide axially along the tubular main body 621 and use the thread to position and lock the current position.

[0085] Continue to refer to Figure 8, the above-mentioned housing docking member 65 includes a columnar insertion portion 651 and a blocking portion 652 connected to one end of the columnar insertion portion 651. An axial insertion hole 650 axially penetrating the columnar insertion portion 651 and the blocking portion 652 is provided inside the columnar insertion portion 651; an external thread is provided on the outer surface of the distal end of the columnar insertion portion 651; a connection hole penetrating the proximal surface of the second housing member 62 is provided at the proximal end of the second housing member 62, and this connection hole communicates with the inner cavity 6001 of the handle housing. An internal thread is provided on the hole wall of this connection hole; the columnar insertion portion 651 passes through the first housing member 61 and then is inserted into this connection hole and is threadedly connected to this connection hole. Thus, the proximal end of the second housing member 62 is fixed to the first housing member 61. The axial insertion hole 650 of the housing docking member 65 communicates with the inner cavity 6001 of the handle housing through the aforementioned connection hole. When the adjustable deflectable guide wire assembly further includes an adjustment core wire 4, this allows the adjustment core wire 4 to be inserted from the axial insertion hole 650 of the housing docking member 65 into the inner cavity 6001 of the handle housing. Preferably, a core wire handle 41 with a radial dimension larger than the diameter of the adjustment core wire 4 is additionally provided at the proximal end of the adjustment core wire 4. The shape of the core wire handle 41 includes but is not limited to a cylindrical shape to further facilitate the operation of the operator.

[0086] Finally, it should be noted that the above-mentioned embodiments and their optional implementation manners in this specification are only used to illustrate the technical solutions of the present invention, rather than limiting them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing optional implementation manners, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that, without conflict, the features of the embodiments and the optional implementation manners in the embodiments in this specification can be combined with each other.

Claims

1. An adjustable curved guide wire assembly, characterized in that: The invention comprises a guidewire body (100), wherein the guidewire body (100) comprises: The core tube (1) comprises a core tube proximal end section (11) and a core tube distal end section (12) pre-bent into a curled shape; The outer bending tube (2) is sleeved on the outside of the core tube (1), and at least the distal tube section thereof is a spring tube (21). The distal end of the spring tube (21) is sleeved on the outside of the distal section (12) of the core tube to form a pre-bent section (211) that is bent into a curled shape following the distal section (12) of the core tube. and a bending adjustment inner tube (3), the bending adjustment inner tube (3) being axially slidably disposed between the outer tube wall of the core tube (1) and the inner tube wall of the bending adjustment outer tube (2), and at least a distal tube section of the bending adjustment inner tube (3) being a straight tube section having a hardness greater than that of the spring tube (21); The bending inner tube (3) is axially slid relative to the core tube (1) and the bending outer tube (2), so that the distal tube section of the bending inner tube (3) can extend into the pre-bent section (211) of the reed tube (21) in the distal direction or withdraw from the pre-bent section (211) of the reed tube (21) in the proximal direction, thereby changing the curvature of the pre-bent section (211) of the reed tube (21), and further changing the curvature of the distal section (12) of the core tube; The adjustable bend guidewire assembly further comprises a detachable operating handle (200), wherein the detachable operating handle (200) comprises a handle shell (6), a handle tube fixing assembly (7), an adjustable outer tube fixing assembly (8), an adjustable inner tube driving assembly (9) and an adjustable inner tube locking member (10); The handle tube fixing assembly (7), the bending outer tube fixing assembly (8) and the bending inner tube driving assembly (9) respectively comprise at least one group of extrusion assemblies, each group of the extrusion assemblies respectively comprises two extrusion structures symmetrically arranged on both sides of the handle shell (6) along the radial direction of the handle shell (6), each of the extrusion structures respectively comprises a columnar connecting member (201) and a soft friction pad (202) connected to one end of the columnar connecting member (201); The inner tube bending adjustment locking member (10) is drivingly connected to the columnar connecting member (201) of the inner tube bending adjustment driving assembly (9), and is used to lock the columnar connecting member (201) of the inner tube bending adjustment driving assembly (9) to the handle shell (6) when the inner tube bending adjustment driving assembly (9) slides axially into place.

2. The adjustable curved guidewire assembly according to claim 1, characterized in that: In the core tube (1), at least the core tube distal section (12) is a solid tube section, and the distal end of the core tube proximal section (11) and the proximal end of the core tube distal section (12) are transitionally connected via a gradually tapered transition section (13) whose diameter gradually decreases from the proximal end to the distal end.

3. The adjustable curved guidewire assembly according to claim 1, characterized in that: The bending outer tube (2) further comprises a straight proximal connecting tube (22); an initial positioning structure (220) for initially positioning the bending outer tube (2) on the bending inner tube (3) is provided between the inner tube wall of the proximal connecting tube (22) and the outer tube wall of the bending inner tube (3); the initial positioning structure (220) comprises an arc-shaped positioning groove (2201) provided on one of the inner tube wall of the proximal connecting tube (22) and the outer tube wall of the bending inner tube (3), and an arc-shaped positioning protrusion (2202) provided on the other.

4. The adjustable curved guidewire assembly according to claim 1, characterized in that: The adjustable bend guidewire assembly further comprises an adjusting core wire (4) for adjusting the hardness of the guidewire body (100); at least the core tube proximal section (11) in the core tube (1) is a hollow tube section, the distal end of the adjusting core wire (4) is inserted into the core tube (1) from the proximal tube opening of the core tube proximal section (11), the proximal end of the adjusting core wire (4) is exposed outside the core tube (1), and the adjusting core wire (4) can slide axially relative to the core tube (1).

5. The adjustable curved guidewire assembly according to any one of claims 1 to 3, characterized in that: The bending adjustment outer tube (2) further comprises a straight proximal connecting tube (22); the proximal connecting tube (22), the proximal end section (11) of the core tube and the bending adjustment inner tube (3) are all hard rigid tubes as a whole; The adjustable curved guidewire assembly further comprises a handle tube (51), a first fixed sleeve (52) and a second fixed sleeve (53); The first fixed sleeve (52) is nested inside the handle tube (51), and the core tube proximal section (11) is nested and connected to the inside of the first fixed sleeve (52) by interference fit; The second fixed sleeve (53) is arranged between the outer tube wall of the proximal end section (11) of the core tube and the inner tube wall of the proximal end section of the bending inner tube (3), and is frictionally matched with the outer tube wall of the proximal end section (11) of the core tube and the inner tube wall of the proximal end section of the bending inner tube (3), respectively.

6. The adjustable curved guidewire assembly according to claim 5, characterized in that: The diameter of the distal tube section of the first fixed sleeve (52) is smaller than the diameter of the proximal tube section, so that a stepped hole (521) is formed between the outer circumferential surface of the distal tube section of the first fixed sleeve (52) and the inner circumferential surface of the distal tube section of the handle tube (51); the proximal tube section of the bending adjustment inner tube (3) is inserted into the stepped hole (521) and frictionally fits with the hole wall of the stepped hole (521).

7. The adjustable curved guidewire assembly according to claim 5, characterized in that: The handle shell (6) is provided with a handle shell inner cavity (6001) extending in the axial direction and penetrating at least the distal end surface of the handle shell (6); at least a portion of the guide wire body (100) located on the proximal side of the proximal connecting tube (22) and the entire proximal connecting tube (22) are inserted into the handle shell inner cavity (6001); At least part of the handle tube fixing assembly (7) is disposed in the handle shell inner cavity (6001) and frictionally cooperates with the outer tube wall of the handle tube (51), thereby fixing the handle tube (51) in the handle shell inner cavity (6001); at least part of the bending outer tube fixing assembly (8) is disposed in the handle shell inner cavity (6001) and frictionally cooperates with the outer tube wall of the proximal connecting tube (22), thereby fixing the proximal connecting tube (22) in the handle shell inner cavity (6001); The handle shell (6) is provided with a long drive hole (6002) which radially penetrates the shell wall of the handle shell (6) and extends axially along the handle shell (6); a portion of the inner tube bending adjustment drive assembly (9) passes through the long drive hole (6002) and extends into the inner cavity (6001) of the handle shell to frictionally engage with the outer tube wall of the proximal tube section of the inner tube bending adjustment (3), and another portion of the inner tube bending adjustment drive assembly (9) is located outside the handle shell (6); the inner tube bending adjustment drive assembly (9) is capable of axially sliding relative to the handle shell (6) along the long drive hole (6002) to carry the inner tube bending adjustment (3) to slide axially along the handle shell (6); The inner tube bending adjustment locking member (10) is movably mounted on the outside of the handle shell (6) and is used to lock the inner tube bending adjustment driving assembly (9) to the handle shell (6) when the inner tube bending adjustment driving assembly (9) slides axially into place.

8. The adjustable curved guidewire assembly according to claim 7, characterized in that: The soft friction pad (202) is arranged inside the inner cavity (6001) of the handle shell, and the columnar connecting member (201) passes through the shell wall of the handle shell (6) along the radial direction of the handle shell (6), wherein: The soft friction pad (202) of the handle tube fixing assembly (7) is frictionally matched with the outer tube wall of the handle tube (51); one end of the columnar connecting piece (201) of the handle tube fixing assembly (7) away from the handle shell inner cavity (6001) is fixed to the handle shell (6) via a fixing piece (203); The soft friction pad (202) of the bending outer tube fixing assembly (8) is frictionally matched with the outer tube wall of the proximal connecting tube (22); one end of the columnar connecting piece (201) of the bending outer tube fixing assembly (8) away from the inner cavity (6001) of the handle shell is fixed to the handle shell (6) via another fixing piece (203); The soft friction pad (202) of the bending inner tube driving assembly (9) is frictionally matched with the outer tube wall of the proximal tube section of the bending inner tube (3); the columnar connecting piece (201) of the bending inner tube driving assembly (9) passes through the driving long hole (6002) and its end away from the handle shell inner cavity (6001) is exposed outside the handle shell (6).

9. The adjustable curved guidewire assembly according to claim 8, characterized in that: The handle shell (6) comprises a first shell component (61), a second shell component (62), a third shell component (63) and a fourth shell component (64); The second shell member (62) comprises a cylindrical body (621) and an end plate (622) connected to the distal end of the cylindrical body (621) and extending radially outward along the cylindrical body (621); the handle shell inner cavity (6001) is provided inside the cylindrical body (621); the handle shell inner cavity (6001) extends along the axial direction of the cylindrical body (621) and passes through the end plate (622); the proximal end of the cylindrical body (621) is docked with the distal end of the first shell member (61) through a shell docking member (65), and the proximal end surface of the end plate (622) and the distal end surface of the first shell member (61) face each other; two rows of first ratchet teeth (601) are respectively provided on the proximal end surface of the end plate (622) and the distal end surface of the first shell member (61) and are arranged radially along the cylindrical body (621) on both sides of the cylindrical body (621); The third shell member (63) and the fourth shell member (64) are respectively arranged on both sides of the cylindrical body (621) along the radial direction of the cylindrical body (621), and second ratchet teeth (602) are respectively provided on the surfaces of both ends of the third shell member (63) and the fourth shell member (64) along the axial direction of the cylindrical body (621); the second ratchet teeth (602) on the proximal surfaces of the third shell member (63) and the fourth shell member (64) respectively mesh with the first ratchet teeth (601) on the distal surface of the first shell member (61). , the second ratchet teeth (602) on the distal end surfaces of the third housing member (63) and the fourth housing member (64) respectively mesh with the first ratchet teeth (601) on the proximal end surface of the end plate (622), and the meshing direction of the first ratchet teeth (601) and the second ratchet teeth (602) allows the third housing member (63) and the fourth housing member (64) to approach each other along the radial direction of the cylindrical body (621) and prevents the third housing member (63) and the fourth housing member (64) from moving away from each other along the radial direction of the cylindrical body (621); In the handle tube fixing assembly (7) and the bending outer tube fixing assembly (8), respectively: at least one of the columnar connecting members (201) of the extruded structure passes through the third shell member (63) and the tubular body (621), and is fixedly connected to the third shell member (63) via a fixing member (203); and at least one of the columnar connecting members (201) of the extruded structure passes through the fourth shell member (64) and the tubular body (621), and is fixedly connected to the fourth shell member (64) via a fixing member (203); In the inner tube bending drive assembly (9), at least one of the columnar connecting members (201) of the extruded structure passes through an axial long hole that is radially penetrating and extends in the axial direction and is provided on the third shell member (63), and at least one of the columnar connecting members (201) of the extruded structure passes through an axial long hole that is radially penetrating and extends in the axial direction and is provided on the fourth shell member (64); The inner tube bending adjustment locking member (10) is movably mounted outside the third housing member (63) and the fourth housing member (64) and is drivingly connected to the columnar connecting member (201) of the inner tube bending adjustment driving assembly (9).

10. The adjustable curved guidewire assembly according to claim 9, characterized in that: The inner tube bending locking member (10) comprises a knob sleeve (101), and a knob thread (603) is provided on the outer circumferential surface of the third shell member (63) and the fourth shell member (64), which is circumferentially around the cylindrical body (621) and axially extending along the cylindrical body (621); the knob sleeve (101) is sleeved on the outside of the third shell member (63) and the fourth shell member (64) and is threadedly connected to the knob thread (603); An end buckle (2011) is provided at one end of the columnar connecting member (201) of the bending inner tube driving assembly (9) which is away from the cylindrical body (621), and an annular groove (1011) extending circumferentially along the cylindrical body (621) is provided on the proximal surface of the knob sleeve (101), and the end buckle (2011) is buckled inside the annular groove (1011); the knob sleeve (101) rotates circumferentially around the cylindrical body (621) and can slide axially along the cylindrical body (621) with the bending inner tube driving assembly (9).

11. The adjustable curved guidewire assembly according to claim 9, characterized in that: The shell docking member (65) comprises a columnar inserting portion (651) and a blocking portion (652) connected to one end of the columnar inserting portion (651); an axial insertion hole (650) axially penetrating the columnar inserting portion (651) and the blocking portion (652) is provided inside the columnar inserting portion (651); and an external thread is provided on the outer surface of the distal end of the columnar inserting portion (651); The proximal end of the second shell member (62) is provided with a connecting hole which passes through the proximal surface of the second shell member (62), the connecting hole being in communication with the inner cavity (6001) of the handle shell, and an internal thread is provided on the hole wall of the connecting hole; the columnar insertion portion (651) passes through the first shell member (61), is inserted into the connecting hole and is threadedly connected to the connecting hole.

Images